Recruiting
Phase 2
Phase 3

Pfizer/BioNTech & Moderna

Sponsor:

DHR Health Institute for Research and Development

Code:

NCT05279365

Conditions

SARS CoV 2 Infection

COVID-19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Pfizer/BioNTech (BNT162b2)

Moderna

Study Details

Brief summary:

The recent rise in infections with the Omicron variant of the SARS-CoV-2 is alarming. Equally disconcerting is the fact that individuals who were previously vaccinated (< 6 months) and have co-morbidities that are considered high risk, are getting re-infected...a process referred to as "breakthrough". There is some evidence that in these high risk individuals, the gradual decrease in immunity against the virus as depicted by a drop in anti-SARS-CoV-2 antibodies, is responsible (partially or wholly) for this reinfection. In this study, we intend to give a booster does Pfizer/BioNTech and/or Moderna and ascertain the levels of antibodies at various times pre and post vaccination. The incidence of infection with SARS-CoV-2 after booster vaccination will also be obtained.

Conditions

SARS CoV 2 Infection

COVID-19

Study ID

NCT05279365

Start date

Jul 30, 2021

Status verified date

Mar, 2022

Completion date

Aug 31, 2023

Anticipated

Primary completion date

Aug 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adults 18 years and over that have been fully vaccinated (2 doses) with the Pfizer/BioNTech COVID-19 vaccine (BNT162b2) and with the 1st booster at least 90 days prior to the 2nd booster
  • Healthcare workers employed by and/or affiliated with DHR Health, Renaissance Medical Foundation, DHR Partners, Starr County Memorial Hospital
  • Any adult with any of the following risk factors for severe COVID-19 disease progression (as outlined by the CDC)

Exclusion Criteria:

  • Previous history of allergic reaction to vaccination
  • less than or equal to 3 months from last booster dose of vaccine
  • active SARS-COV-2 infection
  • less than or equal to 21 days of full recovery from SARS-CoV-2 infection
  • less than or equal to 14 days of any vaccination
  • vaccinated with any other available COVID-19 vaccine other than Pfizer/BioNTech or Moderna
  • Healthcare workers not employed by and/or affiliated with DHR Health, Renaissance Medical Foundation, Star County Memorial Hospital or non DHR Partners

Study Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Administration of Booster Dose

study participant will receive either 30ug in 0.3 ml of Pfizer/BioNTech (BNT162b2) or 0.25 ml of Moderna vaccine administered intramuscularly.

Interventions

Pfizer/BioNTech (BNT162b2)

participants will receive a booster dose (1st booster or 2nd booster) of vaccine

Moderna

participants will receive a booster dose (1st booster or 2nd booster) of vaccine

Primary outcome measure

  • Number of participants infected with SARS-CoV-2 after booster Dose [ Time Frame: 24 months ]
  • Levels of anti-SARS-CoV-2 IgG antibody titers after booster [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Sohail Rao, MD,MA,DPhil

956-362-2387s.rao@dhr-rgv.com

Monica Betancourt-Garcia, MD

956-362-3223m.betancourt@dhr-rgv.com

Locations

Brownsville Independent School District

Recruiting

Brownsville, Texas, United States, 78521

Contacts

Sohail Rao, MD, MA, DPhil

956-362-2387s.rao@dhr-rgv.com

Monica Betancourt-Garcia, MD

956-362-3223m.betancourt@dhr-rgv.com

DHR Health Institute for Research and Development

Recruiting

Edinburg, Texas, United States, 78539

Contacts

Sohail Rao, MD,MA,DPhil

956-362-2387s.rao@dhr-rgv.com

Monica Betancourt-Garcia, MD

956-362-3223m.betancourt@dhr-rgv.com

Edinburg CISD School Based Health Center

Recruiting

Edinburg, Texas, United States, 78542

Contacts

Sohail Rao, MD,MA, DPhil

956-362-2387s.rao@dhr-rgv.com

Monica Betancourt-Garcia, MD

956-362-3223m.betancourt@dhr-rgv.com

Starr County Memorial Hospital

Recruiting

Rio Grande City, Texas, United States, 78582

Contacts

Sohail Rao, MD, MA, DPhil

956-362-2387s.rao@dhr-rgv.com

Monica Betancourt-Garcia, MD

956-362-3223m.betancourt@dhr-rgv.com

More Information

Sponsor

DHR Health Institute for Research and Development

Last update posted

Mar 29, 2022

Last verified

Mar, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by DHR Health Institute for Research and Development on 2022-03-29.